Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy

Trial status:Recruiting
Trial ID:
BNT000-001
NCT ID:
NCT04813627
EudraCT ID:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruiting

Trial Details

This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx), during the course of AdCTx and for a period of up to 630 days (21 months) thereafter, according to CRC stages and disease characteristics. Participants receive no therapeutic intervention as part of this study. This study will identify participants with confirmed Stage II (high risk)/III CRC that are positive for ctDNA after resection who might be potential candidates for the clinical study BNT122-01 (NCT04486378), a study of RO7198457 after completion of standard adjuvant chemotherapy in this patient population. These participants will have the option to enter screening for BNT122-01 at Screening Visit 2 of that study if they meet the eligibility criteria of BNT000-001 during screening. Data from the assessments from this study (BNT000-001) will be carried across to the BNT122-01 study where feasible.

Medical Condition
  • Colorectal Cancer
    • Trial Drug
  • Regular blood sample collection for ctDNA assessment
    • Phase
    N/A
    Type
    Observational
    Estimated Enrolment
    2200
    Estimated Trial Date
    Jul 2021 - Mar 2025

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    Ridley-Tree Cancer Center
    California City, California, United States, 93105
    Status
    Recruiting
    Location
    John Muir Clinical Research Center
    Concord, California, United States, 94520
    Status
    Recruiting
    Location
    Marin Cancer Care
    Greenbrae, California, United States, 94904
    Status
    Completed
    Location
    The Oncology Institute of Hope
    Los Angeles, California, United States, 90033
    Status
    Recruiting
    Location
    Rocky Mountain Cancer Centers - Denver Midtown
    Denver, Colorado, United States, 80218
    Status
    Recruiting
    Location
    Cancer Care Specialists Of Central Illinois Sc (Ccsci) - Cancer Care Center Of Decatur
    Decatur, Illinois, United States, 62526
    Status
    Recruiting